Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
FDA device recall Z-1459-2015 · posted 2015-04-20 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
- Action taken
- Exactech Agents sent a Product Recall Advisory Notice dated February 12, 2015 by mailed to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Recall Inventory Respponse form and return it to Exactech, per the instructions provided on the notice.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 112 devices
- Distribution
- Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada.
- Date initiated
- 2015-02-13
- Date posted
- 2015-04-20
- Date terminated
- 2016-09-29
- Location
- Gainesville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTECH EQUINOXE SHOULDER SYSTEM (K042021) | Exactech, Inc. | 2004-10-26 |